Celldex rindopepimut receives FDA breakthrough therapy designationCelldex Therapeutics announced that the FDA has granted rindopepimut Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma, or GBM. This application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies. An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment in December of 2014.